Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

The Influence of Sarcopenia on Outcomes of Neuroplasty in Patients With Lumbar Spinal Stenosis: a Prospective Observational Study

Sponsors

Lead Sponsor: Asan Medical Center

Source Asan Medical Center
Brief Summary

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.

Detailed Description

Frailty is an aging-related syndrome of physiological decline and correlated with sarcopenia. Furthermore, lumbar spinal stenosis is a common disease in the old population and a neuroplasty is widely used to treat these patients. We postulate that the sarcopenia may be associated with the outcome of neuroplasty in patients with lumbar spinal stenosis, and there is no study about this topic as far as we know.

To evaluate this association, we will use the criteria for sarcopenia which is made by Asian Working Group for Sarcopenia in 2019 in this study. We will compare the outcome of neuroplasty in patients with sarcopenia and without sarcopenia using several tools such as numeric rating scale (NRS), Oswestry Disability Index (ODI), and global perceived effect (GPE) score up to 6 months after the procedure.

Overall Status Recruiting
Start Date May 20, 2020
Completion Date November 30, 2021
Primary Completion Date May 31, 2021
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Change in numeric rating scale (NRS) at 3 months after the procedure Before the procedure and 3 months after the procedure
Change in Oswestry disability index (ODI) at 3 months after the procedure Before the procedure and 3 months after the procedure
Global percieved effect (GPE) score at 3 months after the procedure 3 months after the procedure
Change in Medication Quantification scale (MQS) at 3 months after the procedure Before the procedure and 3 months after the procedure
The percentage of successful responders at 3 months after the procedure 3 months after the procedure
Secondary Outcome
Measure Time Frame
Change in NRS at 1 and 6 months after the procedure Before the procedure, and 1 and 6 months after the procedure
Change in ODI at 1 and 6 months after the procedure Before the procedure, and 1 and 6 months after the procedure
GPE score at 1 and 6 months after the procedure 1 and 6 months after the procedure
Change in MQS at 1 and 6 months after the procedure Before the procedure, and 1 and 6 months after the procedure
The percentage of successful responders at 1 and 6 months after the procedure 1 and 6 months after the procedure
Enrollment 79
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Neuroplasty with Racz catheter

Description: The patient is placed in the prone position with a pillow placed under the abdomen to correct the lumbar lordosis. After sterile preparation and draping, the epidural space via the sacral hiatus using a 16 gauge needle is accessed. Then, the Racz catheter is advanced to the site of adhesions under the fluoroscopic guidance. The target site is determined by the location of pathology on lumbar MRI, preprocedural epidurography, and clinical symptoms before the adhesiolysis. Adhesiolysis is performed through the high-volume administration of medications, which consist of a combination of a steroid, local anesthetics, hyaluronidase, and 5% hypertonic saline. As needed, the catheter remains in the epidural space for two days, with the additional injection on each of the days.

Arm Group Label: patients with lumbar spinal stenosis

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Presence of lumbar spinal stenosis on MRI

- 65 ≤ age <79

- Neurogenic claudication due to spinal stenosis

- Chronic pain above than 3 months despite conservative therapies

- Scheduled for neuroplasty with Racz catheter

Exclusion Criteria:

- Allergy to local anesthetics, contrast dye, or steroid

- Use of anticoagulants or antiplatelet medication

- Coagulopathy or Infection at the insertion site

- Neurological or psychiatric disorders

- Hemodynamic instability due to other underlying disorders

- Prior spine instrumentation

- Vascular claudication

- Refusal to participate in the study

Gender: All

Minimum Age: 65 Years

Maximum Age: 79 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Doo-Hwan Kim, M.D. Principal Investigator Asan Medical Center
Overall Contact

Last Name: Asan Medical Center

Phone: 82-2-3010-3868

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Asan medical center Doowhan KIM, M.D. 82-2-3010-1417 [email protected]
Location Countries

Korea, Republic of

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Asan Medical Center

Investigator Full Name: Doo-Hwan Kim

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: patients with lumbar spinal stenosis

Description: Patients with lumbar spinal stenosis will be scheduled for neuroplasty.

Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov